We’re Speaking Out on Health Issues

NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.

Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.

Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.

NCHR Testimony at 2016 FDA Meeting on Leadless Cardiac Pacemakers

February 18, 2016. Leadless pacemakers have the potential to improve the care of patients with various cardiac rhythm disorders. However, this will require an understanding of how acute adverse events compare and contrast with those of traditional pacemakers. I encourage you to urge the FDA to require comprehensive data regarding the intermediate and long-term safety and effectiveness of leadless pacemakers. Post approval studies should clearly assess these diverse factors. They should provide context regarding the entire spectrum of safety and effectiveness in a way that enables physicians to make sound decisions, and that allows patients to fully and clearly understand the risks and benefits of this new technology.

NCHR Testimony at FDA on Vortioxetine Treatment of Cognitive Dysfunction in Major Depressive Disorder

February 3, 2016. NCHR urges FDA to conclude that there is insufficient data to claim that vortioxetine is effective in providing a meaningful improvement in cognitive dysfunction associated with MDD.

NCHR Testimony at FDA on Allergy Products

January 21, 2016. Allergies can be a life-and-death situation. Treatment options for food allergies could save lives, significantly improve quality of life for many families, and reduce the number of severe reactions from occurring. We must require that clinical trials study all of the necessary variables to help families make informed treatment choices.

NCHR Testimony on Probuphine at FDA Advisory Committee Meeting

January 12, 2016. We need safe and effective treatment options for opioid addiction. Unfortunately, the risk-benefit profile of probuphine does not support its approval for the population studied.

Comments of the Patient, Consumer, and Public Health Coalition on Drug Interactions with Hormonal Contraceptives

December 15, 2015. As members of the Patient, Consumer, and Public Health Coalition, we support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling.